Blood donor assembly



Sept. 21, 1954 J. ADAMS ET AL I 2,689,564

BLOOD DONOR ASSEMBLY Filed Nov. 29, 1951 3 Sheets-Sheet 1 l M l m 5 5351 if 5 25 INVENTORS Jilin a. fldam 3y Jase 411.1 17(1)! ,Duu W MHTTOR/VEYS p 1954 J. Q. ADAMS ETAL BLOOD DONOR ASSEMBLY 3 Sheets-Sheet 2Filed Nov. 29, 1951 r III/III/IIIIIIIII 44 INVENTORS d. fl(ldfft6 Sept.21, 1954 J- Q. ADAMS ET AL 2,689,564

BLOOD DONOR ASSEMBLY Filed Nov. 29, 1951 3 Sheets-Sheet 3 /,/"'4'\ 7 WW7 V BY Jbscya 11mm Patented Sept. 21, 1954 BLOOD DON OR AS SEMBLY "JohnQ. Adams, Rutherford, N. J and Joseph J. Kleiner, Woodmere, N. Y.,assignors to 'Becton Dickinson and Company, Rutherford, N. -J., a"corporationwof New Jersey Application November-29, 1951, SerialNo."258,942

2 Claims. -1

This invention relates to 'a structurally and functionally improvedassembly used in connection with blood donation and transfer; thepresent assembly being also capable of use with liquids other than bloodand certain of the elements thereof being useful apart from'theassembly. The presentapplication is "a continuation in part of ourearlier application for patent filed in the United States Patent Ofiiceon May 15, 1951, and identified under Serial No. 226,462.

It is an object of the invention to furnish apparatus of this nature-andin which a sterile assembly will be instantly-available for use. Aftersuch use (which may involve eitherasingle operation or a series ofsteps) the apparatus may conveniently be discarded if it isimpracticable .or undesirable to clean and sterilize the parts of thesame for reuse.

An additional object is that of providing a cannula or needle as part ofthe assembly; this unit being capable of a ready manipulation althoughit may at alltimes, when not in use, be maintained. in a housed orprotected condition.

Still another object is that of designing an assembly which may "bereadily and economically manufactured; the several components of theassembly being capable of ready connection to each other to furnishaunitary apparatus which maybe employed with facility.

With these and other objects in mind, reference is had to the attachedsheets of drawings illustrating practical embodiments of .the inventionand in which:

Fig. l is a sectional side view-of the upper end of a sealed containerand showing the penetrating cannula moved to apoint adjacent to same;

Fig. 2 illustrates the cannula prior to its seal penetration Fig. 3shows the cannula extending through the seal;

Fig, 4 illustrates the manipulationof the cannula assembly after itsremoval .fromthe seal;

Fig. 5 is a sectional side view of an alternative structure andillustrating a venaneedleassociated therewith;

6 is a perspective view of the entire .assembly but showing .analternative .form of hub design as well as a manipulating plate;

Fig. 7 is a fragmentary perspective view showing the manipulating platedetached .from the cannula hub;

Fig. 8 is a sectional "side view of a puncture needle assembly;

"Fig. 9 shows a holder preferably used'with this assembly;

Fig. 10 is a sideview of the holder with the assembly mounted thereonand in process of application to 'a receptacle;

Fig. 11 is a fragmentary view ofthe receptacle and needle assembly withthe blood in courseof transfer to the receptacle;

Fig. 12 shows :in section one form of tube mounting;

Fig. 13 is a transverse sectional view taken along-lines IS-I13 of Fig.12; and

Fig. 14 illustrates another form of mounting.

Considering the seal-puncturing needle, the numeral It) indicates acannula providedat its outer end -with'a penetrating :point. Theopposite end-of the needle furnishes a hub structure convenientlyembracing a 'flange :portion l1 and a gripping portion, which, asin'F'igswl to 4, may be in the for'mloi a truncated cone 2 having itsouter face formed with -a series of grooves t3. The fiange ll isseparated "from the'conicaliportion I2 by a neck 14 integral with bothof these parts. The *entire hub assembly is, of course, secured in anydesirable and acceptable manner against movement with respect to thecannula iii. The latter projects beyond the rear of the hub assembly. Asshown in Fig. .5 and subsequent views, the truncated cone formation maybe superseded by a hub structure 12' of generally cylindricalconfiguration.

That end of the cannula which extends forwardly of the'hub assembly isenclosed in a sheath or-cap l 5'for1ned of rubber orany other propermaterial. The length of the cap should be in excess of the enclosedneedle'porticn. The outer end of the cap is sealed as at 16. Itsopposite end is mounted againstdeta'chment from the hub assembly byconveniently extending over the flange H into the groove provided by thereduced neck portion I l. The rear end of the cannula is ensleeved bythe end of a tube IT. The latter is preferably a vinyl plastic tubingand has a normal bore diameter substantially identical with the bore ofneedle 10. The end edge of the "tubing may abut the outer end of thegripping portion.

Now considering the intravenous needle shown in Fig. 5, it will be notedthat the body of the same is indicated at Hi. This needle is providedwith the usual pointed outer end portion. At a point suitably spacedfrom this end it is en circled by a hub assembly. The latter preferablyincludes a flange i9 and an enlarged rear portion '20 provided with agroove it. The flange l9 and rear portion are connected by an integralreduced neck "portion 22. The end of tubing ll opposite to that mountingneedle I is connected to the portion of cannula I8 which projectsrearwardly of its hub assembly. The bore of cannula It is preferably thesame diameter as the bore of cannula It]. Therefore, in effect acontinuous uninterrupted passage of constant diameter will extend fromthe pointed end of one needle through to the pointed end of the secondneedle.

Needle i8 is preferably protected by being enclosed in a sheath or cap23. The latter may be formed of any suitable material such as vinyltubing. Its length is such that it conveniently extends substantiallybeyond the pointed end of needle i8 when its opposite end extends intothe reduced neck portion 22 and encloses flange E9. The outer end of thesheath 23 may be obstructed by a plug 24 conveniently of cotton andsaturated with alcohol if desired.

As is well understood by physicians and other skilled personnel, it iscustomary to extend one needle of a set into the vein of the donor. Theopposite needle of that set is caused to penetrate a seal for acontainer, the interior of which is conveniently evacuated. Such acontainer has been shown in Figs. 1 and 6 and indicated by the referencenumeral 25 which may mount a protecting cap (not shown). It is providedwith a neck portion conveniently furnished with an outer thread 26. Themouth or bore of this neck is sealed by a stopper embracing a body 27and a head 28. This stopper may be formed of rubber or other propermaterials but in any event should embody resiliency. It is provided inits upper and lower faces with aligned recesses 29 and 33 as well as 3!and 32. The bases of these recesses are separated by partitions ordiaphragm portions 33 which are relatively thin and disposed in a zonesuch that they will lie below the pouring lip of receptacle 25 when thestopper is in fully seated position. So seated, that stopper will beunder radial compression. Therefore, any perforations of minor sizethrough the diaphragm portions will substantially seal upon withdrawalof the needle which has perforated them.

As heretofore described in connection with Fig. the hub shown in thelower portion of that figure is associated with the intravenous needle.A similar hub may be associated with the stopper-perforating needle 40as shown in Figs. 6 and 7. Thus, in these figures the numeral 34indicates a hub portion formed with a roove 35 and I a reduced part 36over which the inner end of the sheath or cap 31 is ensleeved. A plate38 formed with a notch 39 may be provided as part of the assembly. Thisnotch has extending into it detent fingers d2, the ends of which arecurved inwardly and rearwardly and are separated a distance less thanthe diameter of the base of groove 35. Accordingly, the hub of theneedle 40 may have its groove aligned with these fingers and be pressedrearwardly. It will cam against the fingers and due to the resiliencyincorporated in the latter they will be spread apart to a point at whichthe maximum diameter of the hub groove has passed beyond their mostclosely separated faces. So positioned, the hub of the needle will beretained in association with the plate and the latter will serve as amanipulating portion to permit the operator to force the needle topenetrate the stopper or to withdraw that needle from such stop er.

In this manner no diificulty will be experienced in furnishing agripping portion permitting of the ready manipulation of this needle. Asis obvious the plate may readily be detached from the needle hubwhenever desired. Also as shown in these views the hub of theintravenous needle 45 may, if desired, be plain or knurled. The hub willprovide a manipulatin part for that needle. The two needles areconnected by tubing H as heretofore described in connection with Fig. 5.

It will be understood that the parts of this assembly are manufacturedin accordance with acceptable procedures. They are cleaned, sterilizedand assembled. So assembled an apparatus is furnished in which allessential parts are adequately protected against contamination. Inpackaging, if a surplus or an inadequate amount of air is present thenin effect a breather provision is afforded by the tube 23 through theplug 24. At any time the physician or other tech nician desires toemploy the apparatus it will be instantly available for use. All thatwill be necessary is for the user to remove the assembly from itspackage and if a receptacle such as 25 is to be employed, to remove thecap or other covering (not shown) which maintains the sterility of theupper surface of stopper 2'5. Beyond this the procedure will be asfollows:

The site of the vena puncture is selected and the surface is sterilizedin accordance with ac ceptable technique. If employed, the sheath 23 isstripped from the needle l E or ii and that needle is inserted into thevein. Due to the normal pressure of blood in the vein and thecompressibility of air the blood will flow through the bore of cannulai8 and into tube E, a distance of around 4" to 5". Because of thetranslucent nature of tube ll this will be readily apparent to the user.No clamp will be necessary to prevent the blood from flowing into thetube ii to a greater length or height because air may not escape fromneedle is and sheath i5. Of course if a sheath or its equivalent is notemployed, then any suitable clamping structure or provision may beresorted to when it is desired to prevent a flow of liquid through theassembly. Due to the relatively small bore sizes involved, the assemblywill function as a metering structure to prevent too rapid a dischargeof blood from the vein of a donor. Therefore, no valving mechanism willhave to be associated with the needles or tube.

With the removal of the covering from the neck of receptacle 25 thesterile face of stopper head 28 is exposed. If desired, that face may befurther sterilized. In any event if the assembly embraces the parts asin Figs. 1 to 4 and with cap or sheath l5 in position on the needle asshown in Fig. 1, the point of that needle is brought to a posltionoverlying diaphragm 33 at the base of recess 29. Cap l5 will not enterthat recess. Rather, it will tend to fold or extend angularly withrespect to the axis of needle id as shown in Fig. 2. Therefore,continued pressure upon the hub of the puncturing needle will force thepoint of that needle to penetrate the sheath l5 and to thereuponpenetrate diaphragm 33. Under these circumstances the cap will in effectbe collapsed as shown in Fig. 3. Duringthis projection of the parts itis apparent that if a conical hub portion [2 is provided, the operatorsfingers will easily grip the same and be able to force the parts to thedesired positions. So shifted they will remain in those positionsbecause the resiliency of the sheath [5 under which it seeks toreestablish its initial position, will be far less than the resistanceto movement which occurs due to the frictional contact between the outerface of cannula lil and A the surfaces of the diaphragm 3%. Hub portionsl2 or IE (Fig. 5) will also serve as manipulating acsaecu parts etcpermit :of ithewithdrawal of the :needle from the position k'ShOWIlill]. Fig. :3 to that illustratedinrEig-A. .In thellatterfigurepitwVillbe observedthatithefingers of Ithe operator may grip theend :of :the :cap ror "sheath and .stretch the same. Underztheseacircumstances, thepoint of the :needle will withdraw from theperforation in thecap and :be completely :houserl rand ;substan-- tiallysealed within the latter. Where alplate tilt is employed, it 'may:readily be coupled with a needle such :las 40 :to permit pf:manipulation of the latter.

.As will-be understood-whenthegpointof :needle .I 6 penetrated cap tithebore of the cannula exposed to atmospheric pressure. Therefore, underthepressurerwithimthe-vein,=the blood was free to rise or-flowwithin-tube .1 l from-needle it towards needle :l-fl. Immediately after"puncturing the cap -.or-.sheath the point of needle iii penetrateddiaphragm .31 atithebase of recess 25. Therefore, before blooddischarged from needle t0 the endlof that .needle was .in communicationWiththe interior oftheivesselit as shown in Fig. 3. The body of thatvessel being under vacuum, .the flow .ofblood would, if anything, accelerate through .the tube I 'l. The parts are left in thesepositions.until a-desired. amount .of blood has been taken. When .thishas occurred either bygrasping themeedle. hulror usingla plate such as38, needle It or All is withdrawn from association with the stopper orother seal. Diaphragm portion 33 being under radialcompression itfollows that the perforationinthe latter'will be selfsealing. When cap15 .hasbeen manipulated as in Fig. 4,-needle .tllis enclosed in the cap.Ifdesired, a seriesof tubes or otherreceptacles may now be employed forthe purposeof taking terminal blood samples. These are convenientlyclosed by stoppers similar to thataforedescribed. It will .beunderstoodthat if anysubstantial delay is encountered in taking thesesamples the enclosing ofneedle N! by the cap will preventcoagulation orleakage.

Initaking terminal'bloodsamples -it.is, of course, not necessary toenclose needle in within the cap or sheath in the manner shown in Fig. 4if van undesirable time interval does not elapse. However, .in additionto protecting that needle from contamination the cap wi1las :aforebrought out-prevent continuing discharge of blood from the veinwhen suchcap encloses the needle. .Upon theconclusionofthe operationneedle ill iswithdrawn from the final stopper or seal. .Thereupon needle t8is'withdrawnfrom the vein. [is will be appreciated by employing tubingIl of the characterdescribed "hemolysis is prevented. This will bebecause in efiect a single continuous passage free from constriction andenlargements is provided from "the outer end .of one needle through tothe outer 'end of the second needle. Therefore, the blood in flowingthrough this passage will not be buffeted and subjected to acceleratedas well as retarded "flows with .consequent detriment to the blooddischarged .into receptacle or other "receptacles. The purpose ofrecesses 3 I -32 andany other recesses through the stopper 2 8 will beapparent .in that one or more vents, tubeconnections or other expedientsmay thus be provided and by means of which the contents of thereceptacle :may be caused to flow as desired. As will finally beunderstood, the tubing connecting the two .needles :is preferablyformedof that type-of plastic which'when stretcheditends to return to itsnormalposition. Therefore, .a tight seal is provided between the needlesand athe tubing. Additionally, the bores of all three .are substantiallyconstant throughout the entireassembly. The shrinking of the tube intocontact with the rear needle surfaces .be seen that thestopper-penetrating needle or cannula All may be enclosed ina sheath ofprotective material "4|. This sheath or cap is conveniently provided bya suitable plastic which will have resiliency such that its open endconstricts around andfrictionally engages those portions of the "cannulaassemblywhich are adjacent the hub. The latter asaforedescribed isformed with a groove which :in these views have been indicated by thereference numeral 42. As previously taught, the rear end .portion 43 ofthe cannula is connected bya tube 44 with the vena needle.

A needle manipulating holder and clamp has been shown in Figs. 9 .and'10. This isconveniently formed of :metal and includes a base plate 45formed with a notch "46. In common with the notchstructure heretoforedescribed in connection with :Figs. 6 and 7, arms preferably extend intothis recess .at'a point such that the grooved portion of the needle maybeinserted into the notch and removed therefrom. When in sertedltheneedle 'willibe retained as a unit with plate 45 .and against anyprobability of accidental detachment. Extending upwardly from this plateis a portion *617 formed with a slit d8. The outer end of the latter hasits edges diverging and separated :a distance such that tube it mayreadily be accommodated therein. When this tube is moved downwardly intothe slit it is pinched or constricted to a point where no how of fluidmay occur through it. Due to the retricted series of bores which providethe conduit for the flow :of blood that fiow will be metered so that'there Will'bEiIlO danger or discomfort on the part of the donor. Thestraight edge portions of the slit "it will assure that there will be notendency of the tube "to accidentally ride out of the slit. .A-s shownthe plate adjacent the slit may "be reduced. aslindica'ted at '48. Thisreductiondn thickness "will assure that the edge portions defining theslit :aresufiiciently narrow so that while a proper clamping action mayoccur between them and "the surface of the tube, too great -.africtional contact between these parts will not occur.Thestopper-penetrating needle together with the holder ha e been shownwith the sheath reinovediin Fig. '10. Also, in that View tube 13 3 hasbeen shown in a position Within the slot where it is properlyconstricted.

In using an assemblyof this nature needle iii has the grooved portion 32of its 'hub inserted into notch A portionor" tubing l-6i adjacent thiscannula would then be disposed within the slit and wedged by the edgesof the latter so as to prevent any flow of fluid through tube s i.

. Thereupon,:-if cap 41 is used it may be removed and plate did isgrasped between the thumbs index lingers of 'both hands.By'exerting'asteady straight pressure down on the selected site ofstopper 49 "the latter will be penetrated by the needle. The receptaclefiil which is sealed by this stopper .:may, in common with thereceptacle contain any desirable material such as acid citrate dextrose.This will act as a preservative, anticoagulant and feeding agent for theblood. The receptacle 50 is now inverted as indicated in Fig. 11 andproperly supported. When the vein has been punctured by the needleconnected to the opposite end of tube 44, that tube '44 is removed fromclamping engagement with the slit or slot 48. Plate 45 may now bedetached from the needle. Under these circumstances blood will flow tothe receptacle. Such flow will be accelerated incident to the vacuumexisting within that receptacle. However, as indicated in Fig. 11, theblood will merely bubble to the surface of the body of liquid 5| withinthe same and will not spurt into contact with the receptacle surfaces,upon which it would tend to coagulate. A lack of spurting will bebecause, with a metered flow and substantial constant bore existing fromthe vena needle through to and including the stopper-penetrating needle,there will be no tendency for the latter to act as a nozzle and forsurges to occur within the tube assembly.

After the desired, quantity of blood has been withdrawn tube 44 is againdisposed in clamping relation with the edges of slit 48. Holder plate 45has its notch arranged in line with groove 42 and by lateral movementthe needle is coupled with that holder. By placing the index finger ofeach hand under the opposite ends of the plate a gentle steady pull maybe exerted to withdraw the needle from the stopper. The latter as aforebrought out is preferably self-sealing. The holder may remain on theneedle until terminal bloods are taken. After this operation has beencompleted the intravenous needle is withdrawn. The holder is removedfrom the needle 48 and the latter together with its connected tube andvena needle are discarded.

In the several forms of apparatus as illustrated it is preferred thatthe internal diameter of tube H or 44 be on the order of .05". Byemploying a tube having this bore size with needles of customary gauge,very satisfactory results are achieved. In the average case andemploying a receiving receptacle of accepted capacity, the bleeding timeruns between four and a half and seven minutes. A separate meteringstructure is unnecessary in that the bore sufiiciently controls the flowin a manner entirely satisfactory.

To prevent an accidental detachment of tubing I! from the rear of theneedle, a sleeve 50-as in Fig. 5may be provided of plastic or othersuitable material. 'This sleeve has a bore incorporating a diameter suchthat it may freely receive the tubing in its initial state. However,where that tubing is expanded over the rear of the needle i it will beintimately engaged by the sleeve bore. This will prevent any relativeand accidental movements between that needle and the tube portionmounted thereby. If, instead of threading the sleeve on the tube it isdesired to mount the former by lateral movement, it may be slotted as atin Fig. 5, the width of this slot being less than the exterior diameterof the tube. Thus, the sleeve may be moved laterally so that the tubingpasses similarly to the structure at 50, it may be shifted axially tothe position shown. In both instances the sleevein addition toconstricting the tubing around the rear portion of the cannu1awillprovide a guard preventing the fingers of the operator from axiallycompressing the tubing to enlarge its bore diameter. Accordingly, thedanger of accidental detachment of the needle from the tube is reduced.

Alternative structures in this connection are shown in Figs. 12, 13 and14. In the first two views a needle has been shown at 52 which isprovided with a hub 53 having a rearwardly tapered surface 54 and anextended portion 55 beyond the same. The tube I1 is mounted upon thisportion and a split sleeve 56 is applied to the parts in the mannerdescribed in connection with sleeve 5|. The sleeve 56, having bevelledentrance portions 51, will wedgingly engage tapered surface 54 and thusbe firmly mounted to act as a guard.

As in Fig. 14, the needle 58 may be provided with a hub 59 beyond whicha threaded portion 60 is disposed. In that instance the. sleeve 6! hasits opposite end provided with corresponding threads. Therefor, thissleeve may also be fixedly mounted by the needle assembly. These sleevesmay be formed of metal or other suitable material. As shown, they may beslotted. If desired they might incorporate dimensions such that theirbores engage part of the exterior surface of the tubing ensleeved overthe rear cannula end. Thus, in addition to functioning as guards, theywould serve to further restrain movement of the mounted tube portionwith respect to the needle.

Thus, among others, the several objects of the invention as aforenotedare achieved. Obviously numerous changes in construction andrearrangement of the parts might be resorted to Without departing fromthe spirit of the invention as defined by the claims.

We claim:

1. In an assembly of the character described a needle mounting andmanipulating plate, said plate being formed with a needle-receivingnotch and resilient detent arms extending from said plate into saidnotch and separated a distance such that they cooperate with the hubportion of a needle disposable in said slot.

2. In an assembly of the character described a plate to be secured to aneedle, an upwardly prcjecting extension forming a part of said plate,said extension being formed with a slit defined by spaced side edges toreceive between them and constrict a tube connected to a needle and thethickness of said plate adjacent such edges being reduced.

References Cited in the file of this patent UNITED STATES PATENTS NumberName Date 231,072 McKay Aug. 10, 1880 766,203 Walsh Aug. 2, 19041,050,042 Sellar Jan. 7, 1913 1,522,198 Marcy Jan. 6, 1925 1,961,490Hein June 5, 1934 1,975,360 I-Iarrison 1 Oct. 2, 1934 2,121,123 Eriksonet al June 21, 1938 2,222,371 Nesset Nov. 19, 1940 2,256,657 SwabackerSept. 23, 1941 2,271,288 Cuff Jan. 27, 1942 2,362,537 Butler Nov. 14,1944 2,366,424 Perry Jan. 2, 1945 2,367,806 Shaw Jan. 23, 1945 2,410,546McCabe Nov. 5, 1946 2,442,983 Nesset June 8, 1948 2,452,644 Fields Nov.2, 1948 2,461,558 Meagher Feb. 15, 1949 2,517,490 I-Ivam Aug. 1, 1958FOREIGN PATENTS Number Country Date 567,078 France Nov. 30, 1923 452,825Great Britain Aug. 31, 1936 573,611 Great Britain Nov. 28, 1945 587,280Great Britain Apr. 21, 1947

